Activating the Cholinergic Anti-Inflammatory Pathway in Healthy Volunteers and People With Inflammatory Arthritis

January 6, 2026 updated by: Surf Therapeutics

Activating the Cholinergic Anti-Inflammatory Pathway With Focused Ultrasound Stimulation in Healthy Volunteers and People With Inflammatory Arthritis

This study is designed to investigate whether non-invasive ultrasound (US) that is optimized for stimulation and can elicit an anti-inflammatory response in people with Inflammatory Arthritis as compared to a sham intervention. The primary endpoint is the change in pro-inflammatory cytokines in blood drawn before and after US. Each participant receives 4 experimental US sessions, one of which is randomly assigned to be placebo.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The CAP has demonstrated potential as a treatment for various autoimmune and inflammatory disorders, including inflammatory arthritis (Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis) and Inflammatory Bowel Disease (Ulcerative Colitis and Crohn's Disease).

The target populations for this study include healthy volunteers and individuals aged 22-75 years diagnosed with Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) or Ankylosing Spondylitis (AS) by a board-certified rheumatologist.

Up to 20 healthy volunteers and 40 individuals with RA or PsA will be enrolled. After an initial blood draw, participants will receive either active or sham ultrasound during each visit. There will be a total of 5 visits involving ultrasound, with 2 being a sham and 3 being active. The visit in which the sham is administered will be determined according to the Randomization Table. To ensure participant safety, the ultrasound parameters used for the active sessions will not exceed the FDA's limits.

After the US is completed, participants should be asked to wait in the clinic for a few hours following the completion of the US intervention, after which they will have a second blood draw. Once the second blood draw is completed, participants may leave and resume their regular diet. Participants will be asked to return after 24 hours of their intervention for their third blood draw.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78745
        • Tekton Research
      • Houston, Texas, United States, 77030
        • UT Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Healthy Volunteer Population

Inclusion Criteria:

  • 22-75 years of age
  • Weigh at least 40 kg

Exclusion Criteria:

  • Any physical disabilities, conditions, or diseases that limit the capacity to participate in study procedures or increase the risk of harm as determined by the study PI
  • Unable to provide informed consent
  • Active bacterial or viral infection
  • Class II obesity with a BMI of 35 or higher
  • Pregnant women or those trying to become pregnant
  • Active use of tobacco/nicotine products
  • History of substance use disorder or active regular use of substances (nicotine, marijuana, cocaine, psychedelics, stimulants, etc.)
  • Splenomegaly, asplenia, or splenectomy

Inflammatory Arthritis Population

Inclusion Criteria:

  • 22-75 years of age
  • Weigh at least 40 kg
  • Diagnosis of Rheumatoid Arthritis, Psoriatic Arthritis, or Axial Spondyloarthritis of at least 6 months duration as defined by ACR guidelines
  • Able to continue the same stable dose of immunomodulatory medication(s) while participating in the study

Exclusion Criteria:

  • Unable to provide informed consent
  • Took a JAK inhibitor within the last 4 weeks, or likely to start one while participating in this study
  • Started a conventional synthetic DMARD (csDMARD) within the last 8 weeks or had a change in prescription within the last 4 week
  • Started a Tumor Necrosis Factor (TNF) inhibitor within the last 5 months or had a change in prescription within the last 3 months
  • Started any other biologic or targeted synthetic DMARD within the last 3 months, or likely to start one while participating in the study
  • Started a corticosteroid, had a change in prescription, or on a stable dose = or > 10 mg of prednisone daily within the last 4 weeks
  • Regular use of epinephrine like medications (cold, cough, congestion, or sinus medications, bronchodilators, appetite suppressants)
  • Active use of tobacco/nicotine products
  • History of substance use disorder or likely use of substances during the study period (marijuana, opioids/heroin, cocaine, psychedelics, methamphetamine, etc.)
  • Active bacterial or viral infection
  • Receiving chemotherapy or immunotherapy to treat malignancy
  • Significant immunodeficiency due to underlying illness
  • Class II obesity with a BMI of 35 or higher
  • Pregnant women or those trying to become pregnant
  • Wound, rash, infection, or traumatic injury over the target area
  • Vagal nerve injury or vagotomy
  • Surgery or major traumatic injury in the past 90 days
  • Chronically-implanted medical devices (i.e. pacemaker, AICD, vagus nerve stimulator, spinal cord stimulator)
  • Clinically significant cardiovascular disease
  • CKD Stage 3 or higher
  • Uncontrolled fibromyalgia or other diffuse pain syndromes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Participants will receive active treatment during the visit. There will be a total of 5 visits involving ultrasound, with 2 being a sham and 3 being active. Patient is blinded to the treatment. The visit in which the sham is administered will be determined according to the Randomization Table
Device: Ultrasound Stimulation
Ultrasound therapy will be administered to the appropriate target.
Sham Comparator: Control
Participants will receive a non-active treatment during the visit. There will be a total of 5 visits involving ultrasound, with 2 being a sham and 3 being active. Patient is blinded to the treatment. The visit in which the sham is administered will be determined according to the Randomization Table
Device: Non-active ultrasound stimulation
Non-active ultrasound therapy will be administered to the appropriate target

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor Necrosis Factor Alpha Concentration Differences
Time Frame: Baseline to 2 hours post therapy
Measure the change before and after ultrasound stimulation by immunoassay of blood plasma after challenge with LPS.
Baseline to 2 hours post therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interleuken 1b Concentration Difference
Time Frame: Baseline to 2 hours and 24 hours post therapy
Measure the change before and after ultrasound stimulation by immunoassay of blood plasma after challenge with LPS.
Baseline to 2 hours and 24 hours post therapy
Interleuken IL-6 Concentration Difference
Time Frame: Baseline to 2 hours and 24 hours post therapy
Measure the change before and after ultrasound stimulation by immunoassay of blood plasma after challenge with LPS.
Baseline to 2 hours and 24 hours post therapy
Tumor Necrosis Factor Alpha Concentration Differences
Time Frame: Baseline to 24 hours post therapy
Measure the change before and after ultrasound stimulation by immunoassay of blood plasma after challenge with LPS.
Baseline to 24 hours post therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Surf Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2025

Primary Completion (Actual)

January 5, 2026

Study Completion (Actual)

January 5, 2026

Study Registration Dates

First Submitted

August 3, 2024

First Submitted That Met QC Criteria

August 12, 2024

First Posted (Actual)

August 15, 2024

Study Record Updates

Last Update Posted (Actual)

January 7, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SURF_CLN_002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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